About this trial
This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with feacal incontinence (FI), double incontinence (DI) and controls. Presence and severity of both FI and urinary incontinence (UI) will be evaluated by disease specific questionnaires. Measuring both disease severity and Quality of Life (QoL) is needed to determine the true impact of incontinence. Finally, the impact on quality of life will be compared between both groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years;
Self-reported faecal incontinence.
Disqualifiers
Impossibility to perform the anorectal manometry because of pain, stenosis or organic disease;
Active (peri)rectal inflammation, including abscess;
Pregnancy;
Inability to cooperate during the anorectal manometry
Trial population
All patients referred for HARM for FI are eligible to enroll in the database.
Trial design
Case-control
Prospective
Treatments tested in this trial
Questionnaires
Other interventionDisease specific questionnaires
Treatment groups
Trial outcomes
Primary outcomes
compose a database of patients suffering from faecal or double incontinence
a database will be created
Secondary outcomes
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using jorge and wexner score
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using vaizey score
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using International consultation on incontinence questionnaire
Confirm the role of diarrhea as a major determinant of double incontinence vs faecal incontinence
this outcome will be assessed using clinical frailty score
Sponsors and contacts
Click on the lead sponsor to view all of their trials.